
Scarlet is Europe's only Notified Body specialized in certifying software medical devices and AI, providing a specialized certification process for SaMD manufacturers. The company enables safe, predictable, and continuous market access for life-changing medical technologies, accelerating the transition to universally accessible healthcare. Scarlet is accredited and regulated, focusing on software and AI in medicine, helping customers deliver innovative healthcare solutions efficiently.

Scarlet is Europe's only Notified Body specialized in certifying software medical devices and AI, providing a specialized certification process for SaMD manufacturers. The company enables safe, predictable, and continuous market access for life-changing medical technologies, accelerating the transition to universally accessible healthcare. Scarlet is accredited and regulated, focusing on software and AI in medicine, helping customers deliver innovative healthcare solutions efficiently.
Core offering: Notified Body specializing in certifying software medical devices and AI
Region: Europe
Employee count: 57
Total funding (stated): 26,550,000 USD
Regulatory certification for software medical devices and AI-driven medical products
Medical device regulation / Certification
Total Funding: 26,550,000 USD